BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R2 DIAGNOSTICS, INC.

    Reg #: 1835316 · FEI: 3000210416 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    R2 DIAGNOSTICS, INC.
    Registration Number
    1835316
    FEI Number
    3000210416
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1801 COMMERCE DR.
    City
    SOUTH BEND
    State
    IN
    ZIP
    46628
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082631

    Owner / Operator

    Firm Name
    R2 DIAGNOSTICS, INC.
    Operator Number
    9026432
    Address
    1801 COMMERCE DR., --
    City
    South Bend
    State
    IN
    Postal Code
    46628
    Country
    US
    Correspondent
    MICHAEL J MORRIS

    Products

    Device Name Product Code
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Test, Time, Partial Thromboplastin GGW
    Reagent, Russel Viper Venom GIR
    Control, Plasma, Abnormal GGC
    Test, Fibrinogen GIS
    System, Fibrinogen Determination KQJ
    Plasma, Coagulation Factor Deficient GJT
    Plasma, Control, Normal GIZ
    Test, Time, Prothrombin GJS
    Test, Thrombin Time GJA

    Proprietary Names

    ThromboTek PSe Lupotek KCT LupoTek CorrecTin VL, DetecTin VL, PlasmaConLA FIBRO TEK FIB NOFACT VIII PHOSPHOLLIN-ES AND CALCIUM CHLORIDE PLASMACON NOFACT IX PHOSPHOPLASTIN-RL T-TEK

    Establishment Types

    Manufacture Medical Device